Healios and Athersys Enter Into Regenerative Medicine Partnership for Treatment of Stroke Using MultiStem(R) Therapy

(Thomson Reuters ONE) -




Alliance to Focus on Development and Commercialization of Regenerative Medicine
Products for Stroke and Other Potential Indications Using New Regulatory
Framework in Japan

CLEVELAND and TOKYO, Jan. 08, 2016 (GLOBE NEWSWIRE) -- Healios K.K. ("Healios")
(Tokyo Stock Exchange:4593) and Athersys, Inc. ("Athersys") (NASDAQ:ATHX) have
announced a partnership and license agreement that will focus on the development
and commercialization of novel cell therapy treatments, including MultiStem(®)
for the treatment of ischemic stroke and potentially other indications, in
Japan. The partnership involves MultiStem, a proprietary, patented off-the-shelf
stem cell therapy being developed by Athersys, with an initial focus on treating
ischemic stroke.

Under the terms of the agreement, Healios will gain exclusive rights for the
development of MultiStem for treating ischemic stroke in Japan. Healios will
develop and commercialize the product in Japan, and Athersys will provide the
manufactured product and support to Healios, while retaining all rights outside
of Japan. In addition, Healios will obtain an exclusive option for development
of two additional MultiStem clinical indications in Japan, including the
treatment of Acute Respiratory Distress Syndrome ("ARDS"), which is currently in
clinical development by Athersys in the United States ("U.S.") and the United
Kingdom ("U.K."), and another indication in the orthopaedic area. Healios will
also obtain an exclusive license to incorporate Athersys technology in the
development and commercialization of its proprietary Healios "organ bud"
technology, initially for transplantation to treat liver disease or dysfunction,
which may be expanded upon exercise of the option.

"Stroke represents a major problem, both in Japan and globally. Currently

available treatments such as tPA and mechanical thrombectomy must be
administered within the first several hours after the stroke occurs, limiting
treatment to a small percentage of patients, and such interventions may also
pose certain risks," observed Dr. Kiyohiro Houkin, Chairman and Professor of
Neurosurgery of Hokkaido University Medical School, and President of Hokkaido
University Hospital. "The recently conducted international clinical study by
Athersys in the U.S. and the U.K. suggests that intravenous administration of
MultiStem within 36 hours of the occurrence of a stroke is safe, well-tolerated,
and is a beneficial and effective treatment. The off-the-shelf administration of
the product could be a simple and universal approach for treating acute stroke
patients. Furthermore, it could be administered to patients that do not arrive
at the hospital in time to receive current standard of care, or alternatively
could be administered in addition to tPA or mechanical reperfusion, potentially
enhancing outcomes for patients that have suffered significant strokes. If
efficacy is confirmed in additional studies, it is possible that this therapy
could become the new standard of care for treating stroke," concluded Dr.
Houkin.

As part of the license, Athersys will receive an initial license fee of $15
million, as well as have the opportunity to earn milestone and royalty payments
upon the successful accomplishment of specific development and commercialization
objectives, including the achievement of certain sales milestones.  Development
and approval milestones for stroke could total $30 million, in addition to sales
milestones that could reach $185 million based on successful commercialization
and the achievement of substantial sales of an approved product for treating
stroke in Japan. Athersys will also receive tiered, double-digit royalties
increasing into the high teens on product sales and will be responsible for
providing manufactured product to Healios, subject to receiving reimbursement
under a manufacturing supply arrangement. Furthermore, if Healios elects to
expand the partnership following the successful completion of Athersys' ongoing
clinical trial in ARDS, Athersys will receive a license expansion fee of $10
million for the exclusive rights to two additional indications in Japan, with
the corresponding potential for further milestones based on successful
achievement of specific development and commercialization objectives. As part of
the expanded alliance, Healios will also have the right to incorporate Athersys
technology in other organ bud indications.

Japan currently represents the second largest national market for prescription
biopharmaceuticals in the world. The country is also experiencing a significant
demographic shift that is resulting in a rapid and unprecedented expansion of
the elderly population in Japan, which threatens to pose significant challenges
for the national healthcare system over the next several decades. In order to
help address the challenges posed by the potential increased demand for
healthcare resources as a result of this expanding population, over the past two
years policy-makers in Japan have revised the regulatory framework to focus on
promoting the development of innovative new therapies that are demonstrated to
be safe and that also provide promising signs of effectiveness. These recently
implemented regulatory reforms, which are specifically designed to promote
development of novel regenerative medicine therapies, are intended to speed the
development of promising new medicines for patients where there is substantial
unmet medical need.

Athersys' proprietary cell therapy product, MultiStem, has been evaluated in a
Phase 2 clinical study for ischemic stroke in the U.S. and U.K. and is also in
clinical development in several other indication areas, including the treatment
of ARDS, myocardial infarction, and for transplant support, including prevention
of Graft versus Host Disease and liver transplant support. Athersys has begun
preparations for clinical development in Japan, including engagement with the
Pharmaceuticals and Medical Devices Agency in Japan ("PMDA"). Healios and
Athersys have already met jointly with PMDA and plan to complete additional
preparations for initiation of a clinical study in Japan for stroke, with
commencement of the study expected in the second half of 2016.

"I am very pleased that an exclusive licensing contract has been concluded with
Athersys over development and distribution in Japan of MultiStem, a candidate
pharmaceutical product for innovative cytotherapy having undergone phase 2
clinical trials in U.S. and U.K. There seems to be a large market need for
MultiStem that can expand the period allowed before the start of treatment for
ischemic stroke. Successful development of this product under the new
regenerative medicine framework in Japan could accelerate Healios' ability to
help patients, achieve profitable operations and deliver substantial value to
our shareholders," commented Dr. Tadahisa "Hardy" Kagimoto, President of
Healios. "Beyond stroke, the technology by Athersys is expected to improve the
efficiency of production also when we prepare the organ as a platform for
clinical transplantation programs. In essence, Healios has acquired a catalyst
that can accelerate commercialization in the field of iPSC-based regenerative
medicine products."

Healios is recognized as a leading regenerative medicine company in Japan, with
a technology portfolio that includes the development of retinal pigmented
epithelia cells produced from induced pluripotent stem cells for the treatment
of age related macular degeneration ("AMD").  Healios obtained a license to the
technology from RIKEN to develop a novel treatment for AMD in 2013. Healios has
also licensed additional technology from Yokohama City University related to the
development of organ buds for transplantation indications. Healios is partnered
with Sumitomo Dainippon Pharma Co., Ltd. and SHIBUYA CORPORATION (a leading
robotics company in Japan), as well as NIKON CORPORATION and Osaka University
who are focused on the joint development of advanced manufacturing capabilities
for regenerative medicine therapies.

"Athersys is excited to be working with Healios for the development of MultiStem
in Japan with an initial focus on treating patients that have suffered an
ischemic stroke.  Healios has an experienced and accomplished leadership team
that recognizes the importance and transformational potential of the
regenerative medicine field.  They also have a compelling vision for our
collaboration that includes the potential to work together across several
important indication areas in a highly focused and efficient manner, which is
why we selected them as our new partner," said Dr. Gil Van Bokkelen, Chairman
and CEO at Athersys. "They have a strong balance sheet, an excellent network of
institutional partners and collaborators, and they are committed to rapid and
efficient development under the new regulatory framework in Japan, all of which
are key factors for success."

About Ischemic Stroke

Stroke represents an area where the clinical need is particularly significant,
since it represents a leading cause of death and significantly lowers quality of
life for many stroke victims. Currently, there are more than 15 million people
that suffer a stroke globally and more than two million stroke victims each year
in the United States, Europe and Japan, combined. Ischemic strokes, which
represent the most common form of stroke, are caused by a blockage of blood flow
in the brain that cuts off the supply of oxygen and nutrients and can result in
tissue loss and neurological damage, as well as long-term or permanent
disability. Unfortunately, current therapeutic options for ischemic stroke
victims are limited, since the only available therapies, administration of the
clot dissolving agent tPA, or "thrombolytic," or surgical intervention using
mechanical reperfusion to remove the clot, must be conducted within several
hours of the occurrence of the stroke. As a consequence of this limited time
window, only a small percentage of stroke victims are treated with the currently
available therapy-most simply receive supportive or "palliative" care. The long-
term costs of stroke are substantial, with many patients requiring extended
hospitalization, extended physical therapy or rehabilitation (for those patients
that are capable of entering such programs), and many require long-term
institutional or family care.

About MultiStem

MultiStem cell therapy is a patented regenerative medicine product that has
shown the ability to promote tissue repair and healing in a variety of ways,
such as through the production of therapeutic factors produced in response to
signals of inflammation and tissue damage.  MultiStem therapy's potential for
multidimensional therapeutic impact distinguishes it from traditional
biopharmaceutical therapies focused on a single mechanism of benefit. The
product represents a unique "off-the-shelf" stem cell product that can be
manufactured in a scalable manner, may be stored for years in frozen form, and
is administered without tissue matching or the need for immune suppression.
Based upon its efficacy profile, its novel mechanisms of action, and a favorable
and consistent safety profile demonstrated in both preclinical and clinical
settings, MultiStem therapy could provide a meaningful benefit to patients,
including those suffering from serious diseases and conditions with unmet
medical need. Athersys has forged strategic partnerships and a broad network of
collaborations to develop MultiStem cell therapy for a variety of indications,
with an initial focus in the neurological, cardiovascular and inflammatory and
immune disorder areas.

About Athersys, Inc.

Athersys is an international biotechnology company engaged in the discovery and
development of therapeutic product candidates designed to extend and enhance the
quality of human life. The Company is developing its MultiStem cell therapy
product, a patented, adult-derived "off-the-shelf" stem cell product, initially
for disease indications in the cardiovascular, neurological, inflammatory and
immune disease areas, and has several ongoing clinical trials evaluating this
potential regenerative medicine product. Athersys has forged strategic
partnerships and collaborations with leading pharmaceutical and biotechnology
companies, as well as world-renowned research institutions to further develop
its platform and products. More information is available at www.athersys.com.

About Healios K.K.

Healios is a biotechnology venture leading the field of developing iPS cell-
based products for regenerative medicine. It was founded in 2011 and listed on
the stock exchange (Tokyo Security Exchange Mothers:4593) in 2015. In Japan, the
company is developing a product for treatment of age-related macular
degeneration (an intractable ocular disease) jointly with Suimitomo Dainippon
Pharma Co., Ltd., under the plan of obtaining approval of its
manufacture/distribution in 2020. In fields other than ophthalmology, the
company has started R&D of products for regenerative medicine capable of
creating functional human organs (three-dimensional organs) jointly with
Yokohama City University. The company may be viewed as an enterprise providing
products for regenerative medicine as a solution to the significant global issue
"aging of the society." See the website (https://www.healios.co.jp/) for
details.

Athersys Forward Looking Statements

This press release contains forward-looking statements within the meaning of the
Private Securities Litigation Reform Act of 1995 that involve risks and
uncertainties. These forward-looking statements relate to, among other things,
the expected timetable for development of our product candidates, our growth
strategy, and our future financial performance, including our operations,
economic performance, financial condition, prospects, and other future events.
We have attempted to identify forward-looking statements by using such words as
"anticipates," "believes," "can," "continue," "could," "estimates," "expects,"
"intends," "may," "plans," "potential," "should," "suggest," "will," or other
similar expressions. These forward-looking statements are only predictions and
are largely based on our current expectations. A number of known and unknown
risks, uncertainties, and other factors could affect the accuracy of these
statements. Some of the more significant known risks that we face that could
cause actual results to differ materially from those implied by forward-looking
statements are the risks and uncertainties inherent in the process of
discovering, developing, and commercializing products that are safe and
effective for use as human therapeutics, such as the uncertainty regarding
market acceptance of our product candidates and our ability to generate
revenues, including MultiStem for the treatment of stroke, acute respiratory
distress syndrome and other disease indications. These risks may cause our
actual results, levels of activity, performance, or achievements to differ
materially from any future results, levels of activity, performance, or
achievements expressed or implied by these forward-looking statements. Other
important factors to consider in evaluating our forward-looking statements
include: the success of our collaboration with Healios, including our ability to
reach milestones and receive milestone payments, and whether Healios elects to
expand the partnership or whether any products are successfully developed and
sold so that we earn royalty payments; our ability to raise additional capital;
final results from our MultiStem clinical trials; the possibility of delays in,
adverse results of, and excessive costs of the development process; our ability
to successfully initiate and complete clinical trials; changes in external
market factors; changes in our industry's overall performance; changes in our
business strategy; our ability to protect our intellectual property portfolio;
our possible inability to realize commercially valuable discoveries in our
collaborations with pharmaceutical and other biotechnology companies; our
collaborators' ability to continue to fulfill their obligations under the terms
of our collaboration agreements; the success of our efforts to enter into new
strategic partnerships and advance our programs; our possible inability to
execute our strategy due to changes in our industry or the economy generally;
changes in productivity and reliability of suppliers; and the success of our
competitors and the emergence of new competitors. You should not place undue
reliance on forward-looking statements contained in this press release, and we
undertake no obligation to publicly update forward-looking statements, whether
as a result of new information, future events or otherwise.

Contact:
Athersys, Inc.
William (B.J.) Lehmann, J.D.
President and Chief Operating Officer
Tel: (216) 431-9900
Fax: (216) 432-2461
bjlehmann(at)athersys.com

Healios K.K.
Corporate Communication Group
Tel: 81-(0) 3-5777-8308
Fax: 81-(0) 3-3434-7231
pr(at)healios.jp






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Source: Athersys, Inc. via GlobeNewswire
[HUG#1977537]

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